NPR Health Blog - Wed, 10/05/2016 - 4:05pm
Women had a lot to say about what works — and what doesn't — for treating morning sickness, after we ran a post summarizing the evidence for home remedies and over-the-counter meds.
NPR's Facebook feed lit up with comments from women saying that ginger, acupressure and other home remedies, which were recommended for mild symptoms in a medical journal article published Tuesday, did nothing to tame their nausea and vomiting.
As one woman wrote in response to our post:
If you have severe morning sickness, like I do currently, these things do literally nothing. Don't perpetuate the common conception that morning sickness is a mild woman's ailment that needs ginger tea and an 'it'll pass.' For some it is; for many, it isn't.
Severe morning sickness, called hyperemesis gravidarum, can be debilitating, even life-threatening; it affects about 3 percent of women, according to the American College of Obstetricians and Gynecologists.
We checked in with Dr. Aaron Caughey, chair of the department of obstetrics and gynecology at Oregon Health Science University and an author of ACOG's guidelines on treatment of morning sickness, to ask why it's so hard find effective relief for morning sickness. He replied by email while traveling. (Thank you, airline Wi-Fi!).
One great thing about the conversation in NPR's Facebook feed is that women are sharing a lot of advice on what's worked for them, from specific medications to crackers. Are they on target?
This comment about never having an empty tummy being helpful is something I commonly recommend. It seems like hypoglycemia leads to nausea and then they can't keep anything down and get more hypoglycemic. So I recommend crackers (saltines, goldfish, graham) to be kept in one's purse, next to the bed, etc .... and to eat at least one or two every hour .... at night, when getting up to go to the bathroom, a cracker as well.
I'm wondering if OB-GYNs perhaps give morning sickness less attention because they believe that most women don't have serious problems with it.
I don't know that OB-GYNs are dismissive of these symptoms, as we hear them from many women. It may be that we know that not one approach works for all women, so we have to just cycle through a range of over-the-counter and then prescription approaches.
Then there's the issue of the poor quality of medical research on morning sickness. The JAMA reviewers found that just 35 studies out of 13,000 were strong enough to be included, and those 35 weren't all that great. I'd imagine you had similar experiences with your ACOG review. Why isn't there more good research on morning sickness, considering that most women experience it while pregnant?
There is not enough research on pregnancy, period. During the first trimester of pregnancy, when pregnancy nausea is often the worst, is also the time for embryogenesis. Thus if you want to study a medication that could treat nausea in pregnancy, you would need to do many animal studies first to show that the effect on embryogenesis was nonexistent.
Even by doing so, there still could be an effect on the developing human embryo. Thus this is one of the most challenging conditions to get the pharmaceutical industry to study. Of note, the nausea of pregnancy may have been protective as a species because it kept women from trying to eat potentially embryo-toxic or teratogenic substances.
Women understandably get frustrated when recommended treatments like ginger aren't helping with the nausea and vomiting. When should someone consider moving on to prescription medication to treat morning sickness?
The medications that are commonly used have been used for many years, so are incredibly unlikely to have a negative impact on the developing embryo. In terms of when, this is something to discuss with your obstetric provider. Certainly if hospitalization for fluid has been required, it is time to try medications, but for many women it should be before hospitalization is necessary in order to prevent that from happening.
As a follow-up to that: The ACOG guidelines backed off on recommending the medication Zofran because of concerns that it may be linked birth defects. Do we have enough data to really know what's safe?
The word safe is challenging. I think most of us generally think it is safe to drive in a car, but of course as we all know, it is actually more dangerous than flying. Flying is pretty safe, but of course, there is not a zero risk. So, what risk is one willing to take? With regards to the Zofran issue, recent evidence demonstrated an association with some birth defects as you noted, so while the evidence isn't conclusive, we are trying not to use it except in more extreme cases.
Ultimately, women want to get through the pregnancy and deliver a healthy baby. As awful as severe morning sickness can be, does it pose a risk to the baby?
[Hyperemesis gravidarum] can pose a risk in someone who becomes dangerously dehydrated or in someone who suffers malnutrition for a prolonged period of time. So for someone who is losing a large amount of weight during the first trimester, we would often place a feeding tube to provide nutrition to the pregnant women and ultimately to the fetus.
Fortunately, most women won't have to contend with life-threatening symptoms, but they still feel pretty miserable. What do you tell your patients to help them get though those tough months?
I think one thing is to make sure that they don't feel alone or that they are outliers. Nausea and vomiting are incredibly common, HG is pretty common, too. And it was labeled "morning sickness", but for many women it is all day long, and that isn't abnormal either.
Then it is that we will do things to make sure that this will not get in the way of them being able to nourish their baby, and that even in the worst cases I have seen, the babies grew just fine. It is that we will likely have to try multiple approaches to find a multidimensional one that will work. Thiss may include a range of OTC and prescription treatments.
Finally, this nausea and vomiting eventually goes away in all pregnant women, but rarely is at all at once; it is little by little over time.Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Wed, 10/05/2016 - 1:01pm
Has The Human Life Span Hit The Ceiling? Listen · 3:23 3:23 Toggle more options
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Human life spans have been increasing for decades thanks to advances in treating and preventing diseases and improved social conditions.
In fact, longevity has increased so much in recent decades that some researchers began to wonder: What is the upper limit on human aging?
"We never had so many centenarians as we have now," says Jan Vijg, who studies molecular genetics at the Albert Einstein College of Medicine in New York. "Maybe we can actually live much longer than 100. Maybe this goes on and on and on."
So Vijg decided to try to find out if that's the case. His conclusion, published online Wednesday in the journal Nature: The seemingly inexorable rise in the human life span may have hit a ceiling of about 115 years.
"We cannot break through that ceiling," Vijg says. "The take-home message essentially is this whole ever-increasing life expectancy of humans cannot go on."
Vijg and his colleagues are basing their conclusions on an analysis of decades of longevity records from around the world, including the Human Mortality Database and the International Database on Longevity.
"Every year we looked at who was the one who died in that year and was the oldest human in existence," Vijg says.
The researchers found that the age of the oldest people dying had indeed increased steadily between the 1960s and 1990s, according to their report.
But beginning in the 1990s, "you no longer see that," Vijg says. "You see that it stays the same."
The absolute maximum human life span may be as high as 125, the researchers calculated. But the chances of anyone actually living that long are less than 1 in 10,000.
"If we would have 10,000 worlds like ours, only one individual across all these 10,000 worlds would reach 125 in any given year," Vijg says.
But, he added, "the take-home lesson from what we found is that the human species most likely has a maximum life span of about 115 and we cannot break through that ceiling, at least not as far as we now know."
Other experts say it's not surprising that human longevity may have hit a ceiling.
"Right now, all we're doing is we're combating one disease at a time: heart disease, cancer, stroke," says S. Jay Olshansky, who studies aging at the University of Illinois and wrote a commentary article accompanying the report
"It's like a game of whack-a-mole. You know: One disease goes down another comes up," he says.Shots - Health News Are We Reaching The End Of The Trend For Longer, Healthier Lives?
Olshansky says the only way that could change is if scientists figure out a way to fight the underlying cause of aging, not just individual diseases.
"That would be a game changer," he says.
Scientists are conducting a range of research to try to do that, including studying the genes of families that seem to have a lot of members who live unusually long lives. Some are also trying to identify beneficial substances in the blood of young people that might improve their chances of having a long life, he says.
But no one expects scientists to discover some kind of pharmaceutical fountain of youth anytime soon.Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Wed, 10/05/2016 - 11:03am
Biotrial, a French company that runs clinical studies, has opened a facility in Newark, N.J.Chris Cooper/Biotrial
One man died and four were injured in January after a clinical trial went awry in Rennes, France. Now, Biotrial, the company that ran that study, said it has opened a new research facility in Newark, N.J.
Biotrial conducts clinical trials on behalf of drugmakers and biotechnology companies. Most are phase 1 trials, in which an experimental drug is tried in a small group of volunteers to make a preliminary assessment of its safety before the drug moves on to larger human studies to further evaluate safety and also its effectiveness in treating an illness.
Biotrial's new facility in New Jersey has 110 beds for healthy volunteers participating in clinical trials.Chris Cooper/Biotrial
An announcement Friday from the company said that the new facility would be able to conduct up to 50 phase 1 trials a year, involving as many as 2,000 volunteers. With 110 hospital beds, the facility is just slightly smaller than the company's phase 1 research center in Rennes, which Biotrial says is considered Europe's largest.
The company started conducting trials at the new $30 million facility a few months ago. François Peaucelle, managing director at Biotrial, says it has already completed four, and there are plans or discussions about 20 more.
Peaucelle says that about 55,000 people have participated in company trials since its founding in 1989. He says the tragedy in January was a freak accident. "I compare it to a plane crash. It's very rare, but it can happen," he says. "Medications are never risk free, but diseases are always a risk, so it's important to continue the research. And in drug development, phase 1 is a necessary step."Shots - Health News Botched French Drug Trial Followed Rules But Lacked 'Common Sense'
But John LaMattina, former head of research and development at Pfizer, says the accident strikes him as an important warning. "I don't think the trial was badly done," he says, but it showed poor judgment. LaMattina says that if he were in his old position at Pfizer and someone suggested conducting a trial with Biotrial, "I'd have to say that my response would be 'No.' "
Jack Reynolds, a pathologist who worked for pharmaceutical companies including Pfizer, Bayer, and Bristol-Myers Squibb before founding a preclinical drug discovery company, agrees.
"How does a potential customer look at this?" asks Reynolds. "Not very well, that's for sure. In this business, credibility and reputation are really important."
Biotrial president Jean-Marc Gandon told a French publication that, after the botched trial, the company dropped from doing about 60 phase 1 trials a year to less than six. "The stakes are very high for us because the U.S. market represents 50 percent of global studies on healthy volunteers," he said.
The U.S. Food and Drug Administration said in August that the experimental medication that killed the healthy volunteer and injured four others in France has "a unique toxicity" and wasn't tested in U.S. subjects.Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Tue, 10/04/2016 - 12:38pm
Alberto Ruggieri/Illustration Works/Getty Images
A federal health list specifically guarantees some women's health coverage available without a copay or deductible, so what about men's health? And what options are available for coverage for people who travel frequently? Here are the answers to some recent questions from readers.
Why aren't there preventive health recommendations for men like there are for women under the health law? Women and breast cancer get so much attention by the health care community. Heart health, diabetes, prostate cancer and colon cancer are a few examples of opportunities for education and preventive screening for men.
There are many recommendations for men's preventive care in the health law, although most of the examples you mention apply to women as well. Under the law, services recommended by the U.S. Preventive Services Task Force have to be provided without charging people anything out of pocket. The independent panel of medical experts currently recommends that women and men be screened for high blood pressure, elevated cholesterol and blood sugar levels, and for colorectal cancer.
It advises against routinely screening men for prostate cancer, however, noting that research hasn't shown it reduces death from the disease. (Medicare covers an annual prostate cancer test, but you may owe a copayment.)
The drafters of the health law paid special attention to women's preventive health needs, creating additional recommendations tailored specifically for them. This was done in part to address recognized gaps in women's services, especially in the areas of sexual and reproductive health, said Adam Sonfield, senior policy manager at the Guttmacher Institute, a reproductive health research and policy organization.
The federal government is in the process of updating the women's preventive health guidelines. If it adopts the working group recommendations this fall, insurers will begin to cover condoms and vasectomies for men without charge. Adding this no-cost benefit would address an inequity in current coverage rules and help both women and men avoid unwanted pregnancies.
I am 74 years old and on Medicare. My mother died of ovarian cancer and two maternal aunts and my paternal grandmother had breast cancer. Does Medicare cover BRCA testing?
Medicare generally only covers genetic testing for the two BRCA mutations that are associated with an increased risk of breast and ovarian cancer if you've already been diagnosed with cancer and have a family history that indicates testing is appropriate.
Throughout its history, the Medicare program, which provides health benefits for older and disabled Americans, has focused on treating injury and illness, not preventing them. Although the program now covers some cancer screening tests such as mammograms and colonoscopies, those changes were specifically authorized by Congress.
It's a wrongheaded approach, said Dr. J. Leonard Lichtenfeld, deputy chief medical officer at the American Cancer Society. "I'm incensed that this is not covered."
The BRCA test results could be important not only to the woman but also to her siblings and children, Lichtenfeld said.
The U.S. Preventive Services Task Force recommends that women who have a family history of breast or ovarian cancers be screened to determine if they're at higher risk for potentially harmful genetic mutations and, if appropriate, referred for genetic counseling and BRCA testing. Under the health law, private insurers are required to cover such testing without charging women for it. But that provision does not apply to Medicare.
There are non-insurance options for testing, Lichtenfeld noted. Color Genomics, for example, offers a genetic test that analyzes 30 genes associated with hereditary cancers, including BRCA1 and BRCA2, for $249.
Are there any options available for people with marketplace plans who travel regularly? Emergency costs for an accident should be covered, but what about follow-up care after an accident or an illness while traveling? How does this work with increasingly narrow provider networks?
The situation you describe can be tough to manage. Under the health law, an insurer can't require you to pay more for care in an emergency department that's not in your provider network than it would have mandated for emergency care in network.
But once you leave the emergency department, you may get hit with out-of-network charges if you're admitted to the hospital, for example, or need other follow-up care and are far from home.
You have a few options. Individual Blue Cross Blue Shield plans that are sold on many marketplaces may offer access to BCBS providers nationwide and overseas.
Be sure to check with individual Blues plans before signing up if that type of coverage is important to you, said Paul Rooney, vice president of carrier relations at eHealth.com, an online insurance broker.
"Some of the local Blues are pulling [that coverage] from their offerings," he said.
You might consider buying an accident policy. These plans typically pay a fixed dollar amount to offset your costs if you're injured in an accident. But they can be tricky, said Nate Purpura, vice president of consumer affairs at eHealth.com. The policies don't cover preexisting medical conditions, and the insurer might deny a claim that it considers related to an earlier medical problem, he said.
Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Michelle Andrews is on Twitter: @mandrews110.Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
NPR Health Blog - Tue, 10/04/2016 - 12:16pm
Those acupressure wristbands might not help for seasickness, but they could help for morning sickness.Ruth Jenkinson/Dorling Kindersley/Getty Images
Morning sickness is a fact of life, or at least a fact of pregnancy, with more than three quarters of women enduring nausea or vomiting. There are tons of remedies touted, from ginger to acupuncture. But it can be hard to figure out what works.
And science isn't helping women much. When researchers combed through more than 13,000 studies that addressed morning sickness, they found that just 35 were robust enough to be relied upon. It's not surprising that there's no magic cure-all, especially since any treatment needs to be safe for the mother and the baby. But a few things stood out, especially when it comes to simple remedies for mild to moderate morning sickness. Here's the scoop on treatments you can try at home:
Ginger: Ginger enthusiasts rejoice! One of the oldest anti-nausea tricks in the book seems to work, at least a little bit. Four studies found that ginger was better at relieving morning sickness symptoms than a placebo.
Vitamin B6 (pyridoxine): One study found that vitamin B6 could help with nausea, but that it didn't reduce vomiting any more than a placebo. Another study found that higher doses of vitamin B6 helped reduce symptoms of morning sickness better than lower doses.
Acupressure: You know those wristbands people sometimes wear before going on a boat? They're supposed to put pressure on a certain spot on your wrist and help prevent seasickness. They jury's still out on whether acupressure can cure nautical nausea, but one study found that acupressure bands might help a bit with morning sickness. Others were inconclusive. Acupuncture and electrical nerve stimulation, however, failed to stand up to the jury of clinical trials.
Antihistamines: Some over-the-counter and prescription allergy medications seem to help with morning sickness. Although they are considered safe, they do have side effects like drowsiness and headache, so they're recommended as a second-tier offense. The combination of doxylamine (sold under the brand name Unisom) and vitamin B6 also helped.
What works best? A few studies directly compared the effectiveness of morning sickness treatments. Four compared ginger to Vitamin B6 and found that ginger was just as good, and in one case better, at reducing nausea. Another found that ginger, either in capsules or as syrup, worked better than the motion-sickness bands. And ginger is side-effect free, if you don't count ginger burps or acid reflux. So ginger for the win!
Unfortunately, none of these treatments have instant results.
"The evidence suggests that if these measures are going to be effective, they'll start to help within three to four days," says Amy O'Donnell, a public health researcher and fellow at the National Institute of Health Research School for Primary Care at Newcastle University in Newcastle, U.K., who was an author of the study.
She emphasized that if one at-home treatment doesn't help, women should try something else and consult their doctors.Shots - Health News Women Say Ginger Doesn't Tame Morning Sickness
The study, which was published Tuesday in JAMA, the journal of the American Medical Association, also looked at prescription drugs for moderate and severe morning sickness. The review wasn't conclusive, but it showed that some drugs are effective, including antihistamines and medications that block serotonin and dopamine receptors.
There are other steps women can and should take at the first sign of nausea, says Dr. Laura Sirott, who was not involved in the study. Sirott is a practicing OB-GYN and the California chairman at the American Congress of Obstetricians and Gynecologists.
Dietary changes can help, she says, like eating smaller meals more often, or avoiding foods that are spicy and have strong odors. Some women find eating something solid, like crackers, before having any liquids can help control nausea.
And using simple remedies to control early symptoms of morning sickness can help avoid more severe problems down the line, Sirott says. Vomiting can lead to severe dehydration which can cause more problems, so being proactive can be a big help.
Sirott says the remedies described in the review have worked for some of her patients.
"The evidence isn't great for some of these treatments, but they're really low-risk. If it's not going to hurt, why not try it?" Sirott says. It's hard to evaluate the effectiveness of morning sickness treatments, she says, because morning sickness naturally improves as pregnancy progresses. "Some of these treatments might just be placebos, but if women say they work, that's what matters."
Given the poor quality of many of the studies on morning sickness, it might be a while before scientists can weed placebo from good practice.
"We need appropriately designed, multicenter clinical trials to compare the effectiveness of different treatments at different severities," says O'Donnell. And they need to take into account the outcomes that matter to women, like "improved quality of life and side effects."
While we wait for better research to come in, Sirott likes to remind her patients that morning sickness can be a good thing. "It's a normal part of pregnancy, and it usually means the pregnancy is going well. But that doesn't mean not getting sick is a bad thing, either."Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Tue, 10/04/2016 - 5:00am
Nurses teach patients how to use equipment and do peritoneal dialysis at home.Life in View/Science Source
About half a million Americans need dialysis, which cleans toxins from the body when the kidneys can't anymore. It can cost more than $50,000 a year, and takes hours each week at a dialysis center.
To meet the need, roughly 7,000 kidney dialysis centers have opened across the country. Patients go several times a week and spend half a day undergoing the life-sustaining procedure. Medicare is now taking steps to make it easier for people to do their own dialysis at home.
That sounds like great news to Dr. Robert LaClair, a nephrologist in Helena, Mont., who has an unusually high percentage of patients who do their dialysis at home: 40 percent versus the national rate of about 10 percent. That's largely because LaClair is no fan of how dialysis has traditionally been done in America. He says his patients do better if they're more active participants in their care, rather than passive receivers.
"The way we do dialysis in this country, no one would be saying, 'This is the way we should be doing things,' " LaClair says.
The traditional dialysis routine in a clinic setting is tough on patients, he says. "Often our patients will feel poorly for four, five, six hours, sometimes the rest of the day after a dialysis treatment [in the center]," LaClair says. "They only start feeling better by the next day. And then of course by the time they feel really well, they're back on dialysis again. So it's very hard on people, especially as they get older, to have to go through that kind of treatment."
Contrast that to LaClair's patient, 84-year-old Ward Shanahan. He's a retired attorney who was diagnosed with diabetes a year ago. LeClair prescribed a home dialysis machine that Shanahan uses every night at bedtime. More frequent dialysis means less recovery time, and patients can do it when it's convenient for them, not when centers have appointments available.
"It gives me a life again," Shanahan says.
He has a lakeside cabin he likes to visit in the summer. Being tied to a dialysis center's daytime hours "busts up the week," he says. "I like to be able to get up in the morning, take a shower and go around the world."
Shanahan says his home routine, using something called a peritoneal dialysis machine, isn't particularly difficult. "It's got this sweet-voiced lady telling me what to do," he says about the prerecorded voice from the machine on his nightstand that talks him through properly connecting several slender, clear plastic tubes to it. One plugs into a pre-mixed bag of sugar solution, another to a permanent catheter near his navel. The machine slowly pumps the fluid into his lower abdomen, where it circulates and absorbs bodily wastes through blood vessels in the abdominal lining called the peritoneum. The machine then draws it back out through the same catheter. Another tube snaking away from his machine carries the waste fluids into a toilet in the adjacent bathroom.
Ward Shanahan, 84, does dialysis at home every night while he sleeps.Eric Whitney/MTPR
Peritoneal dialysis is less common than hemodialysis, in which a machine filters the blood itself. Most people who dialyze at home use the peritoneal technique, although it is possible for some patients to perform hemodialysis at home, too.
Shanahan says he often sleeps through most of the fluid cycling, getting about six hours of sleep a night. If there's a problem, he says, his machine, which is about the size of a toaster oven, "has a squawker on it, so I could be sleeping and this thing wakes me up and tells me I've got to fix the line."
But the routine he's now familiar with requires a lot of up-front training. Medicare is proposing to more than double the payment it offers dialysis providers to teach patients how to do it—from the current $50.16 for 1.5 hours of a nurse's time, to $95.57 for 2.66 hours.
Still, that may not be enough to cover actual training costs, says Dr. Frank Maddux, chief medical officer for Fresenius, a large dialysis company. He says the number of Fresenius' patients who dialyze at home has increased from 7 to 11 percent over the last five years.
"I don't know that [the increased payment] will create all the fundamental changes that need to occur, but I think it sets a good, clear direction," Maddux says.
Neither Medicare nor Maddux will say how many more dialysis patients should do the procedure at home. They say that is both a personal and medical choice that isn't right for everyone, and they don't want patients who are happy using dialysis centers to feel pressure to change.
Medicare officials declined to be interviewed for this story, but Maddux says he sees the agency's proposed bump in payment for in-home dialysis training as part of its bigger "triple aim" goal of improving patients' experience while also improving their health and lowering medical costs.
"There are many patients I think that could be much more engaged in their therapy," Maddux says, which he thinks would likely lead to them feeling better. At least one study found that patients who dialyze more frequently feel better and are hospitalized less than those who do it less frequently.
Nephrologist LaClair practices at St. Peter's Hospital in Helena, Mont. He says his patients who switch from the largely passive experience of a center to taking responsibility for their own care at home never want to go back, "even when we've had people having significant problems and issues" doing it themselves.
At St. Pete's, LaClair says, they have had the opportunity to "model dialysis the way think we would want dialysis if we were sick, and that's what we do."
Neither LaClair nor Maddux sees home dialysis as a threat to the viability of the thousands of dialysis centers nationwide. Providers get the same base-level payments for caring for patients whether they do their dialysis at home or in centers. LaClair says maintaining patients on in-home dialysis is cheaper long term, but requires a significant investment up front in training, and he says it's crucial that there is always medical staff on call to help with challenges, including infection control.
Information technology is improving the viability of home dialysis, too. Patients used to have to keep pen-and-paper logs of important health data about their treatments, logs that nurses say were notoriously inaccurate and that they only saw once a month. New machines track patients vital signs in real time and send the data back to providers via the Internet, allowing them to track and even adjust treatments on their computers or smart phones on the fly.
Medicare hopes to implement the payment increase by January 1, 2017.
This story is part of a reporting partnership with NPR, Montana Public Radio and Kaiser Health News.Copyright 2016 Montana Public Radio. To see more, visit Montana Public Radio.
NPR Health Blog - Mon, 10/03/2016 - 5:54am
Japanese Biologist Wins Nobel Prize In Physiology Or Medicine Listen · 3:34 3:34 Toggle more options
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Yoshinori Ohsumi, a professor at the Tokyo Institute of Technology, smiles as he speaks with Japanese Prime Minister Shinzo Abe on a phone during a press conference in Tokyo today, after he was awarded the Nobel Medicine Prize.Toru Yamanaka/AFP/Getty Images
Yoshinori Ohsumi of the Tokyo Institute of Technology has won the 2016 Nobel Prize in Physiology or Medicine for his discoveries about "autophagy" — a fundamental process cells use to degrade and recycle parts of themselves.
Ohsumi, 71, is a professor emeritus at the Tokyo Institute of Technology in Yokohama, Japan. As the sole winner, Ohsumi will receive more than $930,000.
Ohsumi's work opened the path to understanding how cells adapt to starvation and respond to infection, according to statement from the Nobel Assembly at the Karolinska Institute.
Mutations in the genes that control autophagy can lead to a variety of conditions, including cancer, type 2 diabetes and neurological diseases such as Parkinson's and Alzheimers, according to the announcement.
Autophagy, a term that comes from Greek words for "self-eating," is a basic process cells need to function properly.
"Without autophagy, our cells won't survive," says Juleen Zierath, who chaired the committee that selected Ohsumi. "We need autophagy to ward off invading molecules, for example, to deal with very large proteins that might be long-lived or defective. But we also need autophagy for renewal."
Scientists had known about autophagy since the 1960s, but the process had been very difficult to study, according to the Nobel announcement. So the exact machinery involved was unknown, as was how the system worked and whether it was involved in disease.
Before Ohsumi's work, scientists knew there was a structure inside cells that was considered the equivalent of a "waste dump," Zierath says.
"What he showed was that it wasn't a waste dump. It was a recycling plant. This was a really sophisticated machinery that recycled damaged or long-lived proteins," Zierath says.
Ohsumi showed this by conducting a series of "brilliant" experiments in the 1990s using chemically modified baker's yeast to identify key genes that are essential for autophagy, according to the Nobel announcement. These experiments enabled Ohsumi to decipher the complex series of chemical signals and events involved in the process. He then went on to show that similar sophisticated machinery is used in human cells.
"Ohsumi's discoveries led to a new paradigm in our understanding of how the cell recycles its content," according to the announcement. "Intense research is now ongoing to develop drugs that can target autophagy in various diseases."
Ohsumi and the winners of the remaining 2016 Nobel prizes will receive their awards at a ceremony in Stockholm Dec. 10.
"All I can say is, it's such an honor," Ohsumi told reporters at the Tokyo Institute of Technology, according to the Japanese broadcaster NHK. "I'd like to tell young people that not all can be successful in science, but it's important to rise to the challenge."Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Mon, 10/03/2016 - 5:11am
Doll Therapy May Help Calm People With Dementia, But It Has Critics Listen · 3:38 3:38 Toggle more options
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Vivian Guzofsky, 88, holds a baby doll at Sunrise Senior Living in Beverly Hills, Calif. Guzofsky, who has Alzheimer's disease, is calm when taking care of the dolls.Heidi de Marco/Kaiser Health News
Sitting beside a neatly made crib, 88-year-old Vivian Guzofsky holds up a baby doll dressed in puppy dog pajamas.
"Hello gorgeous," she says, laughing. "You're so cute."
Guzofsky, who has Alzheimer's disease, lives on a secure memory floor at a home for seniors in Beverly Hills, Calif. She visits the dolls in the home's pretend nursery nearly every day. Sometimes Guzofsky changes their clothes or lays them down for a nap. One morning in August, she sings to them: "You are my sunshine, my only sunshine. You make me happy when skies are gray."
No one knows whether she believes she is holding a doll or a real baby. What the staff at Sunrise Senior Living do know is that Guzofsky, who can get agitated and aggressive, is always calm when caring for the dolls.
Doll therapy is catching on at nursing homes and other senior facilities across the country. It's used to help ease anxiety among residents with dementia, who can experience personality changes, agitation and aggression. But the therapy is controversial.
Supporters say the dolls can lessen distress, improve communication and reduce the need for psychotropic medication. Critics say the dolls are demeaning and infantilize seniors.
Marilou Roos, 87, rarely speaks and sleeps much of the day. But caregiver Jessica Butler says Roos brightens up when caring for the dolls.Heidi de Marco/Kaiser Health News
Typically, caregivers will give residents the option of holding, changing or dressing the dolls, without saying whether the dolls are babies or toys. Caregivers may also use the dolls to start conversations about the residents' own children or grandchildren.
Care providers who use the technique say the dolls help engage elderly people who are no longer able to participate in many activities.
"A lot of people with Alzheimer's are bored and may become depressed or agitated or unhappy because they aren't engaged," says Ruth Drew, director of family & information services at the Alzheimer's Association.
Caregivers aren't trying to make their charges believe the dolls are real infants, Drew says. They are just "trying to meet them where they are and communicate with them in a way that makes sense to them," she says.
But some care providers do not like the technique.
"They are adults and we want to treat them like adults," says Stephanie Zeverino, who works in community relations at a Belmont Village center in Los Angeles. "These are very well-educated residents."
Staff members there work with residents to play brain games that promote critical thinking, she says. And they use other types of therapy including art and music.
"We want to provide a sense of dignity," Zeverino says.
"Having the doll ... offers them an anchor or a sense of attachment in a time of uncertainty," says Gary Mitchell, a nurse specialist at Four Seasons Health Care facilities in Northern Ireland, and author of a new book: Doll Therapy in Dementia Care: Evidence and Practice.
"A lot of people associate the doll with their younger days and having people to care for," Mitchell says.
However, he acknowledges that doll therapy can perpetuate the stigma associated with dementia that care givers are trying to get away from.
Some families worry about their relatives being laughed at when they engage in doll therapy, Mitchell says. He had the same concerns when he worked at a senior residential center. But when one resident requested that he allow her to continue caring for a doll, he saw the positive impact of the therapy. Mitchell says doll therapy should be used cautiously and more studies are needed.
At Sunrise Beverly Hills, the nursery is set up like a baby's room. A stuffed bear rests inside the wooden crib. On a shelf above are framed photos of Guzofsky and a few other women who regularly interact with the dolls. A few bottles, a Dr. Seuss book and diapers sit on a nearby changing table.
The nursery is just one of several areas designed to engage residents, says Rita Altman, senior vice president of memory care for Sunrise, which has facilities in the U.S., Canada and the United Kingdom. There are also art centers, offices, gardens and kitchens where residents may find familiar objects from their past.
Altman says the nurseries tend to attract residents who have an instinct to care for babies. Some people may not be able to talk anymore, but still find a sense of security with a doll, she says. "You can read it in their body language when they pick up the doll."
When asked what she likes about the dolls, Guzofsky says, "I love babies."Heidi de Marco/Kaiser Health News
Sunrise caregivers also use the dolls to spark conversations by asking questions: How many children do you have? Was your first baby a boy or a girl? What are the best things about being a mom?
The executive director of the Beverly Hills facility, Jason Malone, says he was skeptical about the use of dolls when he first heard about them.
"I almost felt like we were being deceitful," he says. "It didn't feel like it was real."
But he quickly changed his mind when he realized that staff could use the dolls respectfully.
"We don't want to confuse treating our seniors as children," Malone says. "That's not what this activity is truly about."
Guzofsky began caring for the dolls soon after moving into the facility. When asked what she likes about them, she says, "I love babies. I have some very nice ones back where I live now."
Guzofsky's daughter, Carol Mizel, says her mom raised three children and volunteered extensively in Colorado and Mexico before being diagnosed with Alzheimer's about five years ago. Mizel doesn't see any downside to her mother caring for the dolls.
It is a "creative way of dealing with her where she is now," she says.
For some residents, including 87-year-old Marilou Roos, holding the dolls is one of the only times they interact with the staff. Roos uses a wheelchair and rarely speaks. She sleeps much of the day.
"There is not much [Marilou] can participate in," says Vladimir Kaplun, former coordinator of the secure memory floor. "When she spends some time with the babies, she wakes up and she brightens up."
On a recent day, caregiver Jessica Butler sits next to Roos, who holds a doll against her chest and pats her on the back. She kisses the doll twice.
"The baby's beautiful like you," Butler says.
"It's a boy," Roos says. "Five months."
Caring for the dolls is second nature to Roos, who made a career of being a mom to five children, according to her daughter, Ellen Swarts.
It's been difficult for Swarts to watch the decline of her mother, who hasn't called her by name in over a year. Watching her with the dolls helps, Swarts says.
"To see the light in her eyes when she has a baby in her arms, I don't care if it's real or if it's pretending," she said. "If that gives her comfort, I am a-OK with it."
Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
NPR Health Blog - Mon, 10/03/2016 - 12:02am
Brain Game Claims Fail A Big Scientific Test Listen · 3:51 3:51 Toggle more options
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Want to be smarter? More focused? Free of memory problems as you age?
If so, don't count on brain games to help you.
That's the conclusion of an exhaustive evaluation of the scientific literature on brain training games and programs. It was published Monday in the journal Psychological Science in the Public Interest.
"It's disappointing that the evidence isn't stronger," says Daniel Simons, an author of the article and a psychology professor at the University of Illinois at Urbana-Champaign.
"It would be really nice if you could play some games and have it radically change your cognitive abilities," Simons says. "But the studies don't show that on objectively measured real-world outcomes."
The evaluation, done by a team of seven scientists, is a response to a very public disagreement about the effectiveness of brain games, Simons says.
In October 2014, more than 70 scientists published an open letter objecting to marketing claims made by brain training companies. Pretty soon, another group, with more than 100 scientists, published a rebuttal saying brain training has a solid scientific base.
"So you had two consensus statements, each signed by many, many people, that came to essentially opposite conclusions," Simons says.
In an effort to clarify the issue, Simons and six other scientists reviewed more than 130 studies of brain games and other forms of cognitive training. The evaluation included studies of products from industry giant Lumosity, which has been a prominent sponsor of NPR and other public radio programming.
"We went through each paper and tried to look at the kind of evidence it provided," Simons says.
That meant asking questions like: How big was the study? Did it have an appropriate control group? Do the results support the marketing claims made by companies?
The scientists found that "many of the studies did not really adhere to what we think of as the best practices," Simons says.
Some of the studies included only a few participants. Others lacked adequate control groups or failed to account for the placebo effect, which causes people to improve on a test simply because they are trying harder or are more confident.
There were some good studies, Simons says. And they showed that brain games do help people get better at a specific task.
"You can practice, for example, scanning baggage at an airport and looking for a knife," he says. "And you get really, really good at spotting that knife."
But there was less evidence that people got better at related tasks, like spotting other suspicious items, Simons says. And there was no strong evidence that practicing a narrow skill led to overall improvements in memory or thinking.
That's disappointing, Simons says, because "what you want to do is be better able to function at work or at school."
The evaluation got a warm reception from at least some of the scientists who had signed the 2014 letter defending the science behind brain training.
"The evaluation was very even-handed and raised many excellent points," says George Rebok, a psychologist at Johns Hopkins University who has been involved in brain training research for the past 20 years. "It really helped raise the bar in terms of the level of science that we must aspire to."
Rebok, who says he has no ties to brain training companies, remains optimistic that the right program of brain exercises can improve mental functioning and delay the effects of aging.
One reason brain games haven't shown a clear benefit so far, he says, may be that they don't work the brain hard enough or over a long enough time period.
"It takes mental effort and practice to be able to see results," Rebok says. "If we can implement that long range, I think that there will be a big dividend eventually."
In the meantime, the brain training industry is facing scrutiny from the Federal Trade Commission.NPR.
NPR Health Blog - Sun, 10/02/2016 - 6:00am
People might be forgiven for thinking that the Affordable Care Act is the federal government's boldest intrusion into the private business of health care.
But few know about a 70-year-old law that is responsible for the construction of much of our health system's infrastructure. The law's latest anniversary came and went without much notice in August.
The Hill-Burton Act was signed into law by President Harry S. Truman on August 13, 1946 — and its effect on health care in the U.S. was nothing short of monumental. Perhaps more importantly, it stands as an example, warts and all, of how a bipartisan Congress can forge compromises to bolster American infrastructure and boost the well-being of our people.
Known formally as the Hospital Survey and Construction Act, Hill-Burton started as a Truman initiative. In November 1945, only two months after the official end of World War II, he gave a speech to Congress outlining five goals to improve the nation's health. The first and least controversial of these called for constructing hospitals and clinics to serve a growing and rapidly demilitarizing population.
Hill-Burton provided construction grants and loans to communities that could demonstrate viability — based on their population and per capita income — in the building of health care facilities. The idea was to build hospitals where they were needed and where they would be sustainable once their doors were open.
Over the subsequent decades, new facilities sprang up all around the country, including many in the 40 percent of U.S. counties that lacked hospitals in 1945.
By 1975, Hill-Burton had been responsible for construction of nearly one-third of U.S. hospitals. That year Hill-Burton was rolled into bigger legislation known as the Public Health Service Act. By the turn of the century, about 6,800 facilities in 4,000 communities had in some part been financed by the law. These included not only hospitals and clinics, but also rehabilitation centers and long-term care facilities.
In 1997, this type of direct, community-based federal health care construction financing came to an end. However, numerous Hill-Burton clinics and hospitals still exist around the country, specifically financed by a part of law to provide care to those unable to afford it.
"After the passage of Medicare and Medicaid, Hill-Burton ranks right up there among the most important pieces of health legislation in the 20th century," physician and historian Howard Markel told Shots.
Hill-Burton introduced many ideas in health care financing that are still in use today. Chief among them is that hospitals receiving federal monies are obligated to provide free or subsidized care to a portion of their indigent patients. U.S. non-profit hospitals (still the vast majority) must demonstrate evidence of 'community benefit' to maintain tax-exempt status. Providing care to the uninsured is one of the most common ways to meet this obligation.
Grace Hospital in Morganton, N.C., was funded in part by the Hill-Burton Act. Construction began in 1969.Courtesy of Blue Ridge Healthcare Foundation
Another idea rooted in Hill-Burton is federal-state matching, meaning that federal appropriations must be matched by dollars from states, which is how Medicaid is financed.
Hill-Burton also has a poorly remembered dark side: Because of its provenance as a bipartisan law named for a Northern Republican (Sen. Harold Burton of Ohio) and a Southern Democrat (Sen. Lister Hill of Alabama), the law codified the idea of "separate but equal" in hospitals and health care facilities.
In order to achieve compromise and the necessary Democratic votes for passage, Southern Democrat segregationists had to be appeased. When this aspect of the law was overturned in a federal court challenge in 1963, Hill-Burton went on to become a major driver of hospital desegregation.
It seems worth noting that Sen. Hill's surgeon father named him after Dr. Joseph Lister, a pioneer of antiseptic surgery.
A month after enactment of the law, Truman, a Democrat, appointed Republican Sen. Burton to the Supreme Court in a bipartisan gesture that doesn't seem imaginable in today's polarized political landscape. And consider this: Burton was unanimously approved by the entire Senate the same day he was appointed. With no committee hearings! He joined the court the very next day.
"Hill-Burton speaks to an earlier time in our history when the American people and those who represented them had confidence that government could do good things," Markel said. "And that makes it all the more phenomenal to me."
John Henning Schumann is a writer and doctor in Tulsa, Okla. He serves as president of the University of Oklahoma-Tulsa. He also hosts StudioTulsa: Medical Monday for KWGS - Public Radio Tulsa. You can follow him on Twitter: @GlassHospital.Copyright 2016 KWGS-FM. To see more, visit KWGS-FM.
NPR Health Blog - Sat, 10/01/2016 - 8:26am
How We Got Here: Treating Addiction In 28 Days Listen · 3:56 3:56 Toggle more options
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After a string of inpatient rehabilitation stays, Louis Casanova, who lives near Philadelphia, says he is still trying to break his addiction.Ben Allen/WITF
Louis Casanova is playing cards with a friend on the back deck of a recovery house in Philadelphia's northern suburbs.
He's warm and open as he talks about his past few years. The guy everyone calls Louie started using drugs like Xanax and Valium during his freshman year of high school. At age 18, Casanova turned to heroin. About two years later, the rehab shuffle began.
"I relapsed and then I was just getting high. And then I went to treatment again in February of 2015," he says. "Then I relapsed again and went back to treatment."
He's 23 now. He's hurt people close to him and his criminal record, fueled by his drug addiction, is long. By Louie's count, he has been through eight inpatient rehabs. Louis says his stays have ranged from about 18 to 45 days.
"I did 30 days, and after that I came here," he concludes, talking about his latest visit.
A month's stay can be pretty typical among people who go to an inpatient facility.
Anne Fletcher, author of the book Inside Rehab, agrees.
"It certainly is not scientifically based," she says. "I live in Minnesota where the model was developed and a lot of treatment across the country really stemmed from that."
She says the late Daniel Anderson was one of the primary architects of the "Minnesota model," which became the prevailing treatment protocol for addiction specialists. At a state hospital in Minnesota in the 1950s, Anderson saw alcoholics living in locked wards, leaving only to be put to work on a farm.
To find a path for them to get sober and leave the hospital, he came up with the 28-day model.Shots - Health News FDA Boosts Warning On Danger Of Combining Opioids And Anxiety Meds
Marvin Ventrell, executive director of the National Association of Addiction Treatment Providers, has studied the model's history. He says the month-long standard comes from the notion that when "someone is suffering from addiction — and in the days that this began, we're pretty much talking about alcoholism — it made sense to people that it took about four weeks to stabilize somebody."
And then, Ventrell says, "It became the norm because the insurance industry was willing to pay for that period of time."
Now the model has spread to treatment for opioid addiction, even though recovering from addiction to those powerful drugs may require a different method.
Ventrell admits there isn't enough research about the most effective length for an inpatient stay for opioid addiction.
"Treatment centers have to step up and say, 'Just like cancer or heart disease, we're going to measure our outcomes and show them to you,' " he says.
The federal government estimates spending on treatment for all substance abuse will hit a high of $42 billion by 2020. Some people pay tens of thousands of dollars, desperately hoping inpatient treatment will work.
But there's increasing evidence that medication assisted treatment with the synthetic opioids methadone or suboxone can help those addicted by helping to relieve symptoms of withdrawal and reduce craving, especially when paired with strong outpatient counseling and other support.Shots - Health News Doctors Who Treat Opioid Addiction Often See Very Few Patients
Fletcher says it's important for treatment to move away from the default month-long model.
That may be enough for some people, she says, but it "isn't the case for most people. It's like any other chronic disorder, it waxes and wanes."
After his inpatient stays, Casanova is still trying to break his addiction. While he says recovery largely depends on the person, he preferred longer stays because it gave him more time to learn from other patients in a supportive environment. But Casanova is just one person; others prefer inpatient stays that are shorter than a month, followed by intensive outpatient programs.
Casanova relapsed in February, before I talked to him, and recently had to serve some jail time. But he's back in the recovery house, and hoping to soon make the leap to the next stage — a house with even more independence.WITF-FM.
NPR Health Blog - Fri, 09/30/2016 - 1:40pm
Men who may have been exposed to the Zika virus should wait at least six months before trying to conceive a child with a partner, regardless of whether they ever had any symptoms, federal health officials are recommending.
The Centers for Disease Control and Prevention had previously recommended that only men with Zika symptoms had to wait that long. Those who may have been exposed to Zika but never developed any symptoms were told to hold off on trying to conceive for just eight weeks.
But on Friday the agency published revised recommendations based on new evidence indicating the Zika virus can remain in semen longer than had been thought and can be spread by men even if they don't have symptoms.
"The updated recommendations incorporate what's been learned since the previous guidance was released," the CDC said in a statement announcing the change.
"The new time period for couples to wait to attempt conception when the man has possible Zika exposure but no symptoms [is] expected to minimize the risk of sexual transmission around the time of conception and prevent possible early fetal exposure to the Zika virus," the CDC said.
The Zika virus can cause a variety of birth defects when women get infected while pregnant. The most serious birth defect that has been linked to Zika is microcephaly, which causes babies to be born with abnormally small heads and badly damaged brains.
For couples planning to conceive who do not live in a place where the virus is actively spreading, the CDC recommends that men who may have been exposed to the virus by traveling where the virus is being transmitted wait at least six months before trying to conceive.
The virus has spread through Latin America, especially Brazil, and the Caribbean, including Puerto Rico. It has also been spread by mosquitoes in Pacific islands such as Fiji.
For couples who live in a place where the virus is spreading, the CDC recommends that women and men should be tested if they develop any symptoms. Men who test positive should wait at least six months to try to conceive. Women who test positive should wait at least eight weeks. Those who test negative should talk to their doctor about what to do.
The guidelines are less specific for couples who live in a place experiencing an outbreak, such as Miami, but who don't have any reason to believe they may have been infected.
The guidelines recommend that those couples talk to their doctors about what they should do, weighing factors that "might influence pregnancy timing," such as their age, whether they had problems getting pregnant and their fertility.Shots - Health News Congress Ends Spat, Agrees To Fund $1.1 Billion To Combat Zika
The agency stressed that its guidelines could continue to change as new information about Zika becomes available.
The virus has repeatedly surprised health authorities. At first they thought the virus was transmitted only by mosquitoes. Then researchers discovered men could spread Zika to women through sexual contact. The CDC was surprised again when doctors determined women could also spread the virus to men.
The Food and Drug Administration also recently recommended that all blood donations be screened for the virus to minimize the chances that pregnant women could get infected from a transfusion, or sex with someone who had a transfusion.Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Fri, 09/30/2016 - 12:03pm
Mimi Morales recovers in Children's Hospital of Orange Country in late September after surgery for a dental infection she contracted at Children's Dental Group in Anaheim, Calif. She had three permanent teeth, one baby tooth and part of her jawbone removed.Mindy Schauer/Courtesy of The Orange County Register
When people go to the dentist, they generally expect to leave in better health than when they walked in.
But the water that dentists use to rinse teeth sometimes carries infectious bacteria.
The Orange County Health Care Agency in California says that nearly two dozen children who received so-called baby root canals, or pulpotomies, are thought to have developed dangerous bacterial infections. Dentists perform pulpotomies to remove infected pulp inside a baby tooth so the rest of the tooth can be spared.
The infections were caused by Mycobacterium abscessus, which the health department traced back to the water at Children's Dental Clinic of Anaheim.
"The reason we're so concerned is this infection is very hard to treat with antibiotics," says Dr. Eric Handler, health officer with the Orange County Health Authority. Instead, the tissue is surgically removed. "Treatment can be very traumatic and deforming."
As of Sept. 27, three confirmed and 19 probable infections have been linked to the clinic. In each case, the children had to be hospitalized. In an email to Shots, Children's Dental Group CEO Sam Gruenbaum said, "I am currently devoting all of my time and energy to making certain our patients are taken care of."
In a Sept. 23 letter to patients, Gruenbaum asked the families of patients who had received pulpotomies since April 1 at the Anaheim clinic to come in and be examined for signs of infection. The letter said that the Orange County Health Care Agency had found abnormal levels of microbes in the water, and the clinic is no longer using office water for patient procedures.
Deepa Bharath and Courtney Perks at The Orange County Register report that several children have had surgery to treat infections, including a 7-year-old girl who had "three permanent teeth, a baby tooth, and a part of her jaw bone" removed.
Although infections like these are rare, this isn't the first time Mycobacterium abscessus has been traced to a dental office. In Georgia in 2015, more than 20 children who had pulpotomies were later hospitalized with confirmed or suspected mycobacterium infections.
Still, according to the federal Centers for Disease Control and Prevention, the Georgia outbreak of dental mycobacterium infections is the only other one on record. The investigation into Georgia cases found that 1,386 children received pulpotomies and were potentially exposed to the bacteria. But only about 1 percent of them got sick.
"Infections from mycobacterium are very rare," said Dr. Melissa Tobin-D'Angelo, a medical epidemiologist with the Georgia Department of Public Health who investigated the 2015 outbreak. "We don't want to discourage parents from having their children see their dentists two times a year as recommended. The reason children had to have this procedure is because they had decay to begin with."
Investigators learned that the water supply to the building wasn't contaminated. Ultimately, they traced the infection to the dental unit waterlines — the flexible plastic tubes that carry water to the hoses that rinse your mouth.
The researchers weren't surprised that the tubes turned out to be the source of the problem. Keeping waterlines clean can be a challenge for dentists.
A bacterial incubator
Dental unit waterlines are very good at growing bacteria, says Dr. Nuala Porteous, an associate professor of dentistry at University of Texas Health Science Center Dental School in San Antonio. In her research, she looks at how to control infection risks in dental offices, including the microbes that live in waterlines.
Mimi Morales says she's "flabbergasted" that her granddaughter, Mimi, 7, ended up in the hospital with an infection following a pulpotomy in July.Mindy Schauer/Courtesy of The Orange Country Register
"If you think about the last time you went to the dentist, they only use the water sometimes," Porteous says. "It's very start and stop. They work and then they rinse, so there's a lot of stagnant water."
And bacteria love to grow in stagnant water. How prevalent they are is hard to say. A study of dental waterlines in the U.S. found harmful bacteria 68 percent of the time. Still, another study was reassuring, barely finding any contamination in dental offices in London and Northern Ireland.
Mycobacterium isn't the only kind of germ that can thrive in waterlines. Pseudomonas and legionella can, too. Both types of bacteria can cause pneumonia-like illnesses. Despite studies showing that dentists are more likely to have antibodies for legionella than the general population, very few actual illnesses have been directly linked to dentistry.
"These are organisms that are typically found in water and groundwater, things like that," says John Molinari, a microbiologist and professor emeritus at the University of Detroit Mercy School of Dentistry. "They wouldn't normally get you sick. It's when you have high concentrations in a certain person that illness happens." The elderly and people with an underlying illness are most at risk.
"With legionella, you're more likely to get sick when there's a lot of bacteria, like when you get biofilms," says Molinari.
A biofilm is a group of microorganisms — typically bacteria, fungi or a mixture of microbes — that live in a colony. These microbes communicate with each other and even feed and protect each other. And that can make them very hard to remove.
"Think of the plaque that grows on your teeth," says Molinari, "That plaque is a biofilm. At first you can wash it off with water, but after 24 hours you need to brush your teeth and use chemicals to remove it. Even mouthwash alone isn't enough."
The biofilms in waterlines do the same thing. The outer layers might die as cleaning chemicals rush through the pipes, but the inner layers can survive.
A paper published online Sept. 13 in the journal Pathogens and Disease looked at dental practices using industry-standard sterilization techniques. "We found fungi, bacteria, viruses, and protozoa in dental unit waterlines. In our study, decontamination procedures worked but not completely," Damien Costa, at the University of Poitiers in France and the lead investigator on the study, told Shots in an email.
Costa says there aren't any set procedures for sterilizing waterline units in France, where his research was conducted. He hopes his study will provide data that will help the government create guidelines.
In the United States, the CDC says dentists should "consult with the dental unit manufacturer for appropriate methods and equipment to maintain the recommended quality of dental water." Waterlines vary depending on the dental equipment, so a one-size-fits-all approach wouldn't be effective, a CDC spokesman told Shots.
Generally, dental offices use a combination of chemicals. Some are added continuously to the water in low concentrations, while other, stronger disinfectants are used intermittently. Filters and disinfectant cartridges can be added to the ends of lines, and the ADA recommends occasionally draining and purging the waterlines with air.
Dentists should be able to tell if the bacteria-killing maintenance for their equipment is working. Porteous says chairside kits that check for bacteria are available. Dentists can also send water samples to testing companies to make sure bacterial counts fall within CDC guidelines.
The CDC says that the water dentists use should meet the same quality standards as drinking water. But the CDC and the American Dental Association don't say how often dentists should test their water.
"Without water testing, it's impossible to tell if your treatment works," says Mark Frampton, owner of ProEdge Dental Products, a manufacturer of disinfectants for dental lines. Frampton's company also analyzes water quality for dentists. "In our experience, about a third of the time people that have maintenance programs will still fail our tests because they don't always follow the treatment instructions. People don't always do everything perfectly."
Frampton recommends that dentists check their water quality at least quarterly, or more often depending on the treatment product they use.
University of Texas Health Science Center's Porteous recommends dentists check the water coming out of dental lines at least weekly. "I would hope that all dentists take note of these cases that have been occurring recently in Georgia and under investigation in LA," she says. "It's very sad, and I hope that it makes all dental institutions sit up and take note."
Back in California, the dental clinic linked to the mycobacterium infections isn't taking any chances. It will replace its entire water system.Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Fri, 09/30/2016 - 5:00am
The MiniMed 670G hybrid closed loop system is the closest thing yet to an artificial pancreas for people with Type 1 diabetes.Medtronic
The Food and Drug Administration's approval of a new insulin delivery system for people with Type 1 diabetes is a big deal.
With Type 1 diabetes, the pancreas makes little or no insulin so people have to replace it with either multiple daily injections or a pump. In either case, that process involves constant error-prone adjustments, particularly around food and exercise. Over the long term, high blood sugar levels can lead to organ damage, but over-correcting by giving more insulin can cause dangerous low blood sugars that can lead to unconsciousness.
The device, Medtronic's MiniMed 670G hybrid closed loop system, is made up of an insulin pump and continuous glucose monitor (CGM), both of which are already on the market separately. The new part involves the communication between the two devices.
Medtronic's previous system already had a feature that would shut down the insulin pump if the wearer's blood sugar dropped too low. But the 670G predicts when a person's blood sugar is dropping and prevents the low in the first place, and also corrects high blood sugars.
This is the first such machine in the world with that level of automation, and thus it is informally being called the first "artificial pancreas" system.
However, it's called a hybrid rather than a fully closed-loop system because users will still need to signal that they're about to eat and estimate the carbohydrate count of the food so the device can calculate the additional amount of insulin needed. That means there's still the possibility of mistakes. But now if that count is off, the 670G will correct the error automatically.
For people with Type 1 diabetes, the new capabilities mean they can both sleep through the night without worrying about their blood sugars dropping too low and can go through their day without having to think about their diabetes all the time, according to Aaron Kowalski, chief mission officer for the JDRF, the organization that funds much of the "artificial pancreas" research.
"You get almost normalized overnight blood glucose. For people with Type 1 diabetes, that's massively important," he said, adding that the overall 24/7 burden reduction means better quality of life. "The diabetes isn't gone, but [wearers] can think about it less ...This is a historic milestone."
And more systems like this are coming.Shots - Health News Diabetes Technology Inches Closer To An Artificial Pancreas
Medtronic, via the MiniMed division that it acquired in 2001, was the first to market because it's still the only company that manufactures both the insulin pump and CGM technology. But at least five other partnerships between other manufacturers are now developing closed-loop systems, some using already-available pumps and CGMs, others creating new devices. The systems will likely differ from one another in form, user interface and in the algorithmic approaches embedded in the communication software, "so people with diabetes will have more choices," Kowalski says, noting that JDRF is "celebrating Medtronic because it's the first commercial system, but we're supporting the entire field."
Of course, the field still faces challenges. One of the major technological problems is that insulin deposited just under the skin takes too long to begin working; that's why people still need to signal ahead that they're about to eat. The JDRF is currently funding several initiatives working on making faster-acting insulins.
"The faster the insulin works, the more closed the loop will be," Kowalski notes. "It's not easy, but there's a lot of work going on."
Wearability is another issue. Some people simply don't want to be strapped to devices, even if it means better diabetes control. So, the JDRF has recently announced new funding for miniaturization of the devices.
And of course, there's the problem of access. While insurance coverage for insulin pumps is widely established, this is not the case for the CGM component. Medicare doesn't cover CGM technology, meaning that people now must give up those devices or pay out of pocket when they reach age 65. The JDRF is one of several organizations lobbying to change that, as well as to make sure that all payers recognize both the health and economic advantages of new diabetes technologies.
"This is a priority for us," Kowalski says. "We need to make sure people have access. Not just rich people, but anybody who will benefit."
For now, the 670G, which the FDA gave the nod on Wednesday, is approved only for people ages 14 years and older. Medtronic is studying it in children ages 7 to 13 with the aim of making it available for them, too.Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Thu, 09/29/2016 - 2:16pm
Sarepta Therapeutics was awarded a voucher for a fast-track drug review by the Food and Drug Administration when the company's medicine for Duchenne muscular dystropy was approved Sept. 19. Now Sarepta is looking to sell the voucher to the highest bidder.Mick Wiggins/Ikon Images/Getty Images
Drugmaker Sarepta Therapeutics won a big victory when its $300,000 muscular dystrophy drug was approved Sept. 19, despite questions about its effectiveness.
But the company had other reasons to celebrate. It was also awarded the pharmaceutical industry's version of a Willy Wonka golden ticket.
The ticket, known as a priority review voucher, was created by Congress in 2007 to encourage the development of drugs for neglected tropical diseases and was expanded in 2012 to rare pediatric disorders. A company that gets a qualifying drug approved can be awarded a voucher that can be redeemed for a fast-track government review of one of its future drugs. Or the voucher holder can sell the golden ticket to the highest bidder.
A voucher can help a drug company leapfrog a rival.Shots - Health News Controversy Continues Over Muscular Dystrophy Drug, Despite FDA Approval
"The only people who would buy a priority review voucher would be someone who had something that wouldn't merit its own priority review but they want the priority review," says Dr. Tim Coté, a former FDA official who now runs a consulting firm for rare disease drugs.
A voucher guarantees a company that its drug will be reviewed within six months, as compared with the standard 10. But approval isn't assured, just a speedier decision.
The sale of a voucher can earn a lot of money for a small company like Sarepta. Last year, a voucher sold for a record $350 million when AbbVie Inc. bought one from United Therapeutics. AbbVie hasn't disclosed its plans for the voucher.
Members of Congress, the pharmaceutical industry and rare-disease advocates have passionately supported vouchers as a way to spur development of drugs for rare and neglected diseases. But skeptics, including FDA officials and some academics, have questioned whether the program is paying off.
Nancy Goodman, executive director of Kids v Cancer, is a champion of vouchers. She created her foundation after her son died seven years ago of medulloblastoma, a type of brain cancer that often affects children.
There were no drugs available for her 10-year-old son, she said. "I believe and hope we will see a whole crop of pediatric disease drugs because of the program," Goodman said.
Legislation extending the pediatric voucher program through early December passed the House and Senate by unanimous consent and awaits action by President Obama, who is expected to sign it. The program was set to expire Oct. 1.
Advocates are fighting to keep the program authorized until Dec. 21, 2018, as part of the 21st Century Cures Act, which has passed the House and has stalled in the Senate, where backers hope it will be taken up after the elections.
But officials at the FDA, which must implement the vouchers, are at odds with industry and advocates.
Dr. John Jenkins, director of the office of new drugs in the Center for Drug Evaluation and Research at the FDA, has said he supports the overall goal of providing incentives to promote drug development but that the voucher program is wrong.
In December, Jenkins told the industry publication Pharmaceutical Executive that vouchers raise safety concerns because the program requires the FDA to give any drug accelerated review – even when reviewers have to address complex issues. "We're not making pizza here," he said.
Jenkins declined interview requests for this story. FDA spokeswoman Sandy Walsh said, the "FDA has not seen evidence that the program is effective."
Walsh also said the agency is concerned that the voucher program "adversely affects the agency's ability to set its public health priorities" and "the additional workload from the program strains the agency's resources."
The voucher program does require companies to pay an additional user fee of nearly $3 million on top of the standard fee to review a drug, in order to help the agency pay for the program.Shots - Health News Price Rises For Ticket To A Quicker Drug Review By FDA
But the additional money may not be sufficient.
In March, a Government Accountability Office report on pediatric vouchers said FDA officials complain there is too little time to use the money to hire and train additional employees to do accelerated reviews and that the one-time fee does not enable hiring of long-term staff.
The GAO's report said it was too early to say whether the program is stimulating development of drugs for rare childhood disease. Of the seven pediatric review vouchers that have been awarded, four have been sold to other drug companies.
Drugmaker Sanofi has redeemed two pediatric vouchers. For the first, it paid $67.5 million to BioMarin, developer of a treatment for Morquio A syndrome, a rare, inherited disorder, and used it to expedite review of the cholesterol drug Praluent. Later, Sanofi spent $245 million for a pediatric voucher from Asklepion Pharmaceuticals, maker of treatment for a rare childhood metabolic disease. Sanofi said in February it would be used to speed up the FDA's decision on a Type 2 diabetes treatment.
Vouchers don't expire. If a voucher isn't used, it can be sold an unlimited number of times.
Sarepta plans to sell its voucher. Chief Financial Officer Sandy Mahatme told Wall Street analysts the company has already reached out to "a bunch of potential buyers." He said the proceeds would help finance other drugs in its pipeline, pay to scale up its manufacturing capacity and support the company's entry into European markets.
Kaiser Health News is an editorially independent news service supported by the nonpartisan Kaiser Family Foundation. Follow Sarah Jane Tribble on Twitter: @sjtribble.Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
NPR Health Blog - Thu, 09/29/2016 - 1:23pm
Luz Barajas took her son Carlos Cholico to get his flu shot at Crawford Kids Clinic in Aurora, Colo., last year. Health officials say there is some evidence the flu shot is more protective than the nasal flu vaccine.Brent Lewis/The Denver Post via Getty Images
Federal health officials are urging all Americans to get their flu shots as soon as possible, and are especially concerned that too few elderly people are getting vaccinated.
"Flu is serious. Flu is unpredictable," Dr. Thomas Frieden, the director of the Centers for Disease Control and Prevention, told reporters during a joint briefing Thursday with the National Foundation for Infectious Diseases. "Flu often does not get enough respect."
While the influenza virus causes relatively mild illness in most people, the disease can lead to tens of thousands of deaths during severe flu seasons, Frieden noted. About 100 children die each year from the flu.
The CDC and other infectious disease specialists are concerned by a recent drop in seasonal flu vaccination. About 45 percent of the U.S. population got vaccinated against the virus last year, which was down 1.5 percentage points from the previous year.
The largest decrease was among people ages 50 and older. There was a 3.4 percentage-point drop among people ages 50 to 64, and a 3.3 percentage-point drop among those ages 65 and older. The elderly are among those most vulnerable to life-threatening complications of the flu.
As many as 168 million doses of flu vaccine should be available this year, and more than 93 million have already been distributed, according to the CDC.
"There's plenty for everybody," Frieden said.Shots - Health News Yes, It Is Possible To Get Your Flu Shot Too Soon
Although some questions have been raised about whether getting the flu vaccine too soon may diminish its effectiveness, federal officials recommended against anyone waiting. Similarly, some research recently questioned whether protection from the vaccine may wane more quickly among people who get vaccinated every year. But the CDC and other infectious disease specialists still advocate annual vaccination.
The nasal spray vaccine, which many parents have preferred for their children, is not being recommended this year because recent research has questioned its effectiveness. Researchers are still trying to confirm if and why the nasal version might be less effective than the shot.
But two new flu vaccines are available this year. One protects against four strains of flu instead of just three. The other contains a substance known as an "adjuvant," which boosts the vaccine's effectiveness.
Health officials recommend that most people simply get whichever version of flu shot is most readily available to them rather than wait for a specific version.Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Thu, 09/29/2016 - 12:04pm
Rats That Reminisce May Lead To Better Tests For Alzheimer's Drugs Listen · 1:55 1:55 Toggle more options
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Rats are great at remembering where they last sniffed the strawberries.Alexey Krasaven/Flickr
What rats can remember may help people who forget.
Researchers are reporting evidence that rats possess "episodic memories," the kind of memories that allow us to go back in time and recall specific events. These memories are among the first to disappear in people who develop Alzheimer's disease.
The finding, which appears Thursday in Current Biology, suggests that rats could offer a better way to test potential drugs for Alzheimer's. Right now, most of these drugs are tested in mice.
"We need to have a way to study the exact type of memory that we think is impaired in Alzheimer's disease," says Bruce Lamb, a professor of medical and molecular genetics at Indiana University in Indianapolis. He was not involved in the study.Shots - Health News Genetically Modified Rat Is Promising Model For Alzheimer's
The lack of an adequate animal model of Alzheimer's disease may be one reason drugs that seemed to work in mice have failed when given to people, Lamb says.
Loss of episodic memories, especially recent ones, is a key sign of Alzheimer's, says Jonathon Crystal, an author of the study and director of the neuroscience program at Indiana University in Bloomington.
"So if you visit your grandmother who has Alzheimer's, [she] isn't going to remember that you were visiting a couple of weeks ago and what you described about things that are going on in your life," he says.
Crystal and a team of researchers thought rats might have some form of episodic memory. So they began doing studies that relied on the animals' remarkable ability to recognize a wide range of odors, like basil and banana and strawberry.
The latest study, led by graduate student Danielle Panoz-Brown, tested the animals' ability to remember whether they had detected a particular combination of odors, and, if so, where that event had occurred.
"And what we find is that the rats are really adept at this," Crystal says. The animals remembered more than 30 odor events, a finding that suggests their brains can handle a large number of episodic memories.
So far, mice have been used for most animal research on Alzheimer's. That's because they are cheaper and because of the wide availability of lab mice that have been genetically altered to develop brain diseases similar to Alzheimer's.
But there's evidence that rat brains have more in common with human brains. And researchers are developing rat models of Alzheimer's that seem to do a better job mimicking the human disease.
So it may be time to give rats another look, says Lamb, who is co-leading a $25 million, government-funded effort to develop better animal models of Alzheimer's.
"We're going to initially focus on mice," he says, because they are so widely used by researchers. "But we hope to expand this to rats."Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Thu, 09/29/2016 - 5:00am
A multi-million dollar effort to produce a test to guide treatment for a potentially lethal skin cancer recently fell apart after the scientific investigator discovered that the commercial antibodies he was using were unreliable.Cultura RM Exclusive/Peter Mulle/Getty Images
Researchers trying to understand diseases and find new ways to treat them are running into a serious problem in their labs: One of the most commonly used tools often produces spurious results. More than 100 influential scientists met in California this week and agreed on a strategy to address the troubling issue.
The tool in this case is a process — the use of custom-built antibodies. Like the antibodies in your body that help fight off disease, these customized research antibodies are also designed to home in on a specific target, this time to help scientists decipher the invisible workings of a cell.
Dozens of companies around the world produce more than 2.5 million varieties of these antibodies. It's a billion-dollar industry.
The antibodies may be genetically engineered, or they may be produced by injecting a substance into an animal, and then filtering and purifying (from the animal's blood) antibodies produced in reaction to that injected substance.
Unfortunately, these commercial antibodies often don't work as advertised. One common and serious problem is that they latch onto the wrong target — fooling the researchers who are putting them to use.
In one iconic case, a multi-million dollar effort to produce a test to guide treatment for melanoma fell apart, after the researcher conducting the cancer study discovered that his antibodies were utterly unreliable.
Scientists are becoming increasingly aware of this problem and increasingly concerned. A surprisingly large share of research conducted in one lab can't be reproduced elsewhere, and "antibodies are a very large contributor to the problem," says biochemist and biophysicist Dr. Joshua LaBaer, who heads the Biodesign Institute at Arizona State University.
LaBaer was among the scientists gathered in Asilomar, Calif., this week to talk about ways to make the antibodies more reliable, and the research more rigorous.
Last year, some researchers concerned about iffy antibodies came up with a set of guidelines for how companies can validate their antibodies to make sure they perform as advertised.
These ideas were "very much supported at the conference," says microbiologist Mathias Uhlen from the Royal Institute of Technology in Stockholm, who chaired last year's international working group and also helped organize the conference in California.
Scientists from academia, industry and government agreed at the conference that what's needed is a specific set of standards that antibody production companies should all use to test their products. Those ratings would allow customers to make head-to-head comparisons between competing products before buying antibodies.
Though complying with such standards would be voluntary, Uhlen argues that they would encourage companies to produce higher grade products and to compete on quality. It's an open secret in this field that many smaller companies in this billion-dollar industry produce cheaper but inferior products.
This is not a quick fix. Tests to validate antibodies are time-consuming and expensive, and sorting through the more than 2 million antibodies on the market today would be a Herculean task.
The National Institutes of Health, which provides $30 billion a year to support biomedical research, is reluctant to insist that scientists use only validated antibodies.
"NIH clearly views themselves as a funder, not a regulator," says Leonard Freedman, a molecular geneticist who runs a nonprofit called the Global Biological Standards Institute, which organized the Asilomar meeting.
Part of the problem also lies with poor training of young scientists working in university research labs, Freedman says. GBSI surveyed scientists about their use of antibodies in preparation for the meeting and discovered that 31 percent of young scientists didn't even think it was necessary to validate the antibodies they rely on in their labs, even though bad antibodies could completely invalidate their findings.
"It was pretty shocking," Freedman says.
Email Richard Harris at email@example.com.Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Wed, 09/28/2016 - 3:56pm
A health department microbiologist looks for mosquitoes carrying Zika virus in Hutchins, Texas.LM Otero/AP
After nearly seven months of bickering and finger-pointing, Congress on Wednesday agreed to allocate $1.1 billion to help fight the spread and effects of the Zika virus.
The deal is part of a broader agreement to continue to fund the government after the fiscal year ends on Friday and the current budget expires.
It brings to an end a partisan fight that has had the unusual effect of delaying funding to deal with what all sides agree is a public health emergency. The delay came out because of disagreement over side issues like funding for Planned Parenthood and whether the money should be considered "emergency" spending.
Wednesday's deal drops language barring the money from going to Planned Parenthood clinics. The Senate passed the measure Wednesday afternoon; the House passed it Wednesday night.
"Women's health should never be treated like a political football," said Sen. Patty Murray, D-Washington, who is the ranking member of the Senate's Health Education Labor and Pensions Committee. "I am glad that Republicans finally agreed to set aside the extreme provisions that would have specifically blocked Planned Parenthood health care providers from accessing critical funding."
More than 23,000 people in the mainland U.S. and Puerto Rico have contracted the Zika virus, according to the Centers for Disease Control and Prevention. That includes more than 2,000 pregnant women, which is especially troubling because the virus can cause birth defects.
The CDC estimates that 20 babies in the mainland U.S. and 1 baby in Puerto Rica have been born with birth defects related to Zika.
The Zika virus can cause microcephaly — a condition where a baby's head and brain are undersized and underdeveloped — in as many as 13 percent of babies born to women who get infected while pregnant. It is also linked to several other types of birth defects, and to Guillain-Barre syndrome in adults.
The deal reached in Congress includes $394 million to help control Zika-carrying mosquitoes and another $397 million to help develop a vaccine against the virus and better tests to help diagnose cases of Zika.
There is also $66 million allocated to health care for people affected by Zika in Puerto Rico and other U.S. territories.
President Obama asked for $1.9 billion in emergency federal funding back in February to fight Zika. The administration has been using money shifted from other accounts, including money that had been specified for studying and fighting Ebola, and for state-level emergency preparedness, to address the Zika threat.
Earlier this month Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, warned that his agency would run out of funds to fight Zika by Friday. Health and Human Services Secretary Sylvia Burwell issued a similar warning in August.Copyright 2016 NPR. To see more, visit NPR.
NPR Health Blog - Wed, 09/28/2016 - 10:48am
A job reviewing drug applications at the Food and Drug Administration can be the springboard for a career in industry.Andrew Harnik/AP
More than a quarter of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies, according to research published by a prominent medical journal Tuesday.
Dr. Vinay Prasad, a hematologist-oncologist and assistant professor at Oregon Health and Science University, sought to understand the so-called "revolving door" between the FDA and the pharmaceutical industry, which he said is often discussed but hadn't been quantified.
"We all know about these anecdotal cases" of a person who was "often a major player at the FDA, someone in an important role — and then they leave the FDA and go and work for industry," Prasad said, but he couldn't find anyone who knew whether this happened "5 percent or 60 percent" of the time.
Prasad and his colleague Dr. Jeffrey Bien, an internal medicine resident also at OHSU, tracked 55 FDA reviewers in the hematology-oncology field from 2001 through 2010, using LinkedIn, PubMed and other publicly available job data. The researchers found that of the 26 reviewers who left the FDA during this period, 15 of them, or 57 percent, later worked or consulted for the biopharmaceutical industry. Put another way, about 27 percent of the total number of reviewers left their federal oversight posts to work for the industry they previously regulated.
Prasad and Bien published their findings as a research letter in The BMJ, formerly The British Medical Journal.
Going to work for industry after leaving the FDA isn't inherently bad, but it does raise some questions.
"If you know in the back of your mind that your career goal may be to someday work on the other side of the table, I wonder whether that changes the way you regulate," Prasad said. "Are you more likely to give [companies] the benefit of the doubt? Are you less likely to beat them up hard over [using bad comparisons in drug studies]?"Shots - Health News FDA Fees On Industry Haven't Fixed Delays In Generic Drug Approvals
Prasad focused his research on his own field — hematology-oncology — because it spawns a large number of new drugs and reviewers have a lot of autonomy, he said.
"There's a lot of room for interpretation in deciding whether or not a cancer drug should be approved," he said, because so many studies of cancer drugs rely on what's called a "surrogate endpoint," meaning that something other than survival or quality of life was measured to determine whether a drug worked. For example, shrinking a tumor may be a stand-in for survival. But according to one of Prasad's previous studies, there isn't always evidence that surrogate endpoints are linked to better health outcomes for patients, suggesting that some approved drugs aren't as beneficial as they appear.
"Sometimes, the public needs [the FDA reviewers] to be firm. If they're not, no one else in the health care sector is going to be," Prasad said, adding that once the agency approves a drug, the Centers for Medicare & Medicaid Services has to cover it and can't negotiate prices under current laws. "The FDA is often the only real wall between ineffective, harmful drugs and patients."
He and Brien tracked reviewers instead of higher ranking officials because reviewers provided a larger sample size, Prasad said. They would have liked to include reviewers named on denials as well, but the denial documents are secret, making it impossible to identify the reviewers.
Although Prasad said FDA reviewers have a lot of power over approvals, Dr. Joshua Sharfstein, the FDA's principal deputy commissioner until 2011, disagreed.
"There are just so many checks and balances within the review process that it's really not up to one person by and large," said Sharfstein, now an associate dean at the Johns Hopkins Bloomberg School of Public Health in Baltimore. "Key regulatory decisions are looked at from many different angles. I think it would be very difficult for an individual to do something inappropriate and not have that caught."
Sharfstein said he has met with companies to offer advice, but wasn't compensated for it.
The revolving door is a fair topic to study, he said, but having former FDA officials on the pharmaceutical industry payroll can have a public health benefit. Former FDA employees with deep knowledge of the approval process can help make it go smoother by ensuring all the relevant research is complete and that the latest pathways to approval are understood.
FDA spokesman Jason Young said employees leave the government to work for industry at various agencies, not just the FDA.
"The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to advantage any company, organization or individual," he said, adding that these include protecting confidential information they learned at the FDA and a cooling-off requirement for senior officials before they can work for industry.
Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Follow Sydney Lupkin on Twitter:@slupkin.Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.